140925 OLAW mod Sig Change - SSilk

Guidance on Significant Changes to
Animal Activities
Notice Number: NOT-OD-14-126
Release Date: August 26, 2014
Resources: Significant Changes to
Previously Approved Animal Activities
NIH Guide Notice NOT-OD-14-126
OLAW Webpage Significant Changes
Resources: Significant Changes to
Previously Approved Animal Activities
OLAW Special Seminars: Guidance on Significant Changes
to Animal Activities: Recording, transcripts and resources
Susan Silk, MS, OLAW
George Babcock, PhD, U of Cincinnati
Jerry Collins, PhD, Yale University
Betty Goldentyer, DVM, USDA, APHIS, AC
Mary Lou James, BS, IACUC 101 Series
Cynthia Gillett, DVM, University of Minnesota
Major Points
Significant changes to animal activities may now be handled by several
methods as per NOT-OD-14-126.
1. Certain specific significant changes MUST be reviewed and
approved by either FCR or DMR.
2. Other specific significant changes MAY be administratively
handled using an IACUC-established mechanism of veterinary
verification and consultation (VVC) when there is an IACUC
approved policy that addresses the specific significant change.
3. Requests for increases in animal numbers
MAY be administratively handled using an IACUC established
mechanism for doing so and according to an IACUC policy
describing allowable increases.
Also Permitted
Other allowed activities:
4. Minor changes MAY be administrative handled by
institutional personnel who support the IACUC
without IACUC approval, policies, consultation, or
5. Use of fewer animals than approved by the IACUC
does NOT require administrative handling, IACUC
approval, policies, consultation, or notification.
IACUCs now have 3 methods for handling significant
changes to previously approved animal activities:
1. Classic handling of specified or all significant changes:
2. Administrative handling of procedures performed on
animals through veterinary verification and
consultation (VVC) by IACUC-designated veterinarian.
3. Administrative handling of increases in animal numbers.
1: Classic
Significant changes that can ONLY be approved by FCR or DMR
 from nonsurvival to survival surgery;
resulting in greater pain, distress, or degree of invasiveness;
 If USDA regulated, literature review is required
 in housing and or use of animals in a location that is not part
of the animal program overseen by the IACUC;
in species;
in study objectives;
in Principal Investigator (PI); and
that impact personnel safety.
The IACUC MAY choose to require review of other significant changes
by FCR or DMR.
1. OLAW USDA Expectations
Some significant changes require FCR or DMR and may
NOT be approved by VVC or administrative handling.
The IACUC may not develop and approve policies
regarding administrative changes to these activities.
2: Veterinary Verification and Consult (VVC)
Some significant changes may be administratively handled
according to IACUC-approved policies with verification by
and in consultation with an IACUC-authorized veterinarian:
 anesthesia, analgesia, sedation, or experimental
 euthanasia to any AVMA approved method
including those approved with conditions as long as the
conditions are met,
not permitted to have a policy that allows change to a
euthanasia method that is not approved in AVMA Guidelines;
duration, frequency, type, or number of procedures
performed on an animal.
2. Advantages of VVC
Permits research team to immediately apply some
significant changes to all animals under the protocol.
Avoids delays associated with writing and submitting
an amendment for IACUC review and approval and
reduces the risk of compromising an ongoing research
Reduces regulatory burden.
2. OLAW USDA Expectations of VVC
IACUC policies (guidance documents, SOPs and formularies) that
address significant changes must be written, reviewed, and
approved before they are implemented.
IACUC policies must be reviewed and approved by consensus at
least every 3 years by methods that include:
 FCR or DMR;
 polling by telephone calls or email; or
 posting policies in an electronic format for IACUC member
IACUC members are expected to understand and be familiar with
their policies.
2. IACUC Responsibilities of VVC
 Designate: The IACUC must authorize veterinarian(s)
to administratively handle significant changes by VVC.
 Vet must understand IACUC policies and have lab
animal training or experience.
 Does not have to be AV or IACUC member.
 May be identified by title, role, or name.
 Document and record: IACUC must establish a
mechanism for documenting significant changes
handled by VVC.
2. Vet Responsibilities of VVC
 Certify that an IACUC policy covers the requested
significant change.
 Determine if the change is appropriate for the specific
Consult: Recommend modifications if appropriate and
within the scope of the policy.
Defer: Refer the significant change for FCR or DMR by the
IACUC, if indicated.
2. IACUC Policy Does Not Apply
What if a significant change is requested, but not covered
under an IACUC policy?
 The PI sends an amendment to the IACUC for review and
 IACUC modifies an existing policy to include the
requested change according to the IACUC-established
mechanisms for making modifications to IACUC policies.
 IACUC develops a new policy that addresses the
requested change, according to the IACUC established
mechanisms for developing, reviewing, and approving
IACUC policies.
3. Administrative Handling
of Animal Numbers Increase
An increase in previously approved animal numbers
may be handled administratively according to an
existing IACUC reviewed and approved policy WITHOUT
additional consultation or IACUC-notification
3. Expectations of Administrative Handling
of Animal Numbers Increase
IACUC must have a policy that describes increases in
animals numbers that can be handled administratively,
permitted changes (e.g., percentage, range, or number),
and who may approve the change (e.g., IACUC
IACUC policy may be written broadly for all species or
may be written specifically by species (e.g.,
rodents, dogs, NHPs).
The original rationale for the numbers of animals should
continue to support the increase in number, range or
percent being requested. If not, a revised rationale is
required .
4. Administrative Changes
Administrative changes may be managed without IACUCapproved policies, consultations, or notifications:
 correction of typographical errors;
 correction of grammar;
 contact information updates; and
 change in personnel, other than the PI
(An administrative review must be conducted to ensure that all
such personnel are appropriately identified, adequately trained
and qualified, enrolled in occupational health and safety
programs, and meet other criteria as required by the IACUC.)
5. Administrative Change
The use of fewer animals than approved may be handled
without IACUC policy, approval, notification, consultation,
or administrative handling.

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